Comments on women in clinical trials

Comments on women in clinical trials

Comments on FDA’s proposed guideline about including women in clinical trials of drugs are being accepted until Nov. 19.

The proposal was published in the Federal Register last July 22, and also discussed in an issue of the New England Journal of Medicine published at that time.

The new guideline encourages companies to continue to include both women and men in drug development and to analyze effectiveness and safety, looking for gender differences in response to medications.

The guideline directs particular attention to possible effects of the menstrual cycle, menopause, and use of oral contraceptives or estrogens.

At the same time, FDA revised a 1977 policy that had excluded women of childbearing age from early studies of most drugs. Elimination of this restriction reflects the agency’s view that institutional review boards, investigators, and patients should play a greater role in deciding whether participation of women in trials is appropriate and how best to make sure the fetus is not exposed to potentially toxic agents.

FDA will continue to evaluate the risks and benefits of drug studies in specific populations, including women. The general principles about including women and analyzing gender differences outlined in the guideline also apply to biological products and medical devices.

Comments on the guideline may be submitted to the Dockets Management Branch, HFA-305, Room 1-23, 12420 Parklawn Drive, Rockville, MD 20857.

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